SOP on Standard Operating Procedures In Pharma Industry
- To lay down a procedure for preparation, review, approval, distribution, control & revision of Standard Operating Procedure In Pharma Industry.
- This procedure is applicable to all SOP’s of the formulation plant of Pharma Industry.
- Personnel (originating department) – Preparation of SOPs.
- Department Head / nominee (originating department) – Checking of SOPs.
- Head-QA– Approval of SOPs.
- QA Personnel – for control, issuance, retrieval and destruction of SOPs.
- Head – QA / Plant Head shall be accountable for compliance of SOPs.
- Following procedure shall be used for preparation of SOP.
- All SOPs shall be written and prepared in the format given in Annexure -01.
- All SOPs shall be written in English language.
- The language used in SOP shall be clear, instructive, sequential, and unambiguous.
- Where required, SOP may be additionally prepared in vernacular language for easy understanding of the support functions. Contents of such SOP shall be verified and certified for accuracy by QA (Quality Assurance).
- Classification of SOPs In Pharma Industry:
All the SOPs shall be classified in 3 categories, viz.
- General SOPs (GN) -which are applicable to all the departments/ areas in the plant.
- Sub-general SOPs (SG) – which are applicable to more than one department /areas.
- Specific SOPs (SP) – which are applicable to specified department/ areas.
SOP numbering procedure :
- Each SOP shall be assigned a unique SOP number by QA department.
- All the SOPs shall be numbered in the following manner.
- Each SOP shall be numbered as an alphanumerical number consisting of 13 characters. For example, SOP on preparation of SOPs shall be numbered as
- The first 2 characters “XX” represent the originating department.
- The SOP numbering shall follow the below mentioned guidelines for department prefix:
|Originating Department||Department/ Area Prefix|
|Production – Oral (Tablets, Capsules & Dry Syrup)||PO|
|Personnel & Administration||PA|
- The 3rd character ‘-‘ is a dash.
- The 4th and 5th characters “YY” represent the category of the SOP, for example ‘GN’ shall mean General SOP.
- The 6th character ‘-‘is a dash and the 7th, 8th and 9th characters “ZZZ” denote the serial number of the SOP.
- The 10th character ‘-‘ is again a dash and 11th, 12th and 13th (last 3) characters “R00” denote the revision number of the SOP.
- For example, general SOP may be numbered as “QA-GN-001-R03”, where “QA” refers to the concerned department prefix, “GN” refers to the “general” category of SOP, “001” refers to the sequential number of the SOP and “R01” refers to the sequential revision / version number of the SOP.
- For example, sub-general SOPs may be numbered as “QA-SG-001-R00”, where “QA” refers to the concerned department prefix, “SG” refers to the “sub-general” category of SOP, “001” refers to the sequential number of the SOP and “R00” refers to the sequential revision / version number of the SOP.
- For example specific SOPs may be numbered as “QA-SP-001-R00”, where “QA” refers to the concerned department prefix, “SP” refers to the “department specific” category of SOP, “001” refers to the sequential number of the SOP and “R00” refers to the sequential revision / version number of the SOP.
Revision / version number – Each SOP shall have a revision / version number. If any SOP is prepared for the first time, its revision / version number shall start with ’R00’ and continue sequentially for later revisions / versions.
- All the points in the SOP shall be numbered sequentially. Similarly the sub-paragraphs of each point shall also be numbered sequentially, with an incremental number derived from the Heading number. A military system of numbering shall be followed as under:
For example if the Heading number is 1, the sub-headings shall have sequential numbers as 1.1, 1.2, 1.3 and so on. Each step under the sub-heading 1.2 shall be numbered as 1.2.1, 1.2.2 and so on. In case where numbering of sub-paragraph is not necessary, and listing is essential, bullets or other suitable identification marks may be used to illustrate the same.
Creation of SOP In Pharma Industry
- The following guidelines may be used for drafting an SOP.
- An SOP shall be neatly typed using a computer (Microsoft Word) and printed in black ink on A4 size white paper (on one side of the paper only).
- The font type and font size of the printed letters, including Header and footer, shall be uniform (Arial 11), except for where bold text is required in case of header, headings & note.
- For an SOP typing, the following page setup / word formatting details may be used preferably:
- Top / Bottom / Left Margins = 1 inch
- Right Margin = 0.7 inch
- Gutter (from edge) Header / Footer = 0.8/1.0 inch
- Page Border (from Text) = top 4 points / bottom 0 points
- Page Border (from Text) = left / right 12 points
- Numbering Indent = 0 inch
- Hanging Indent / left tab = 0.75 inch
- Line spacing = single, Heading / Subheading = Bold letters
- Paragraph spacing (before & after) = 6 points
Each page of standard operating procedure consists of header at the top and details as mentioned below:
- All characters of header are to be mentioned in bold fonts
- The header consists of 8 rows. Rows no 1, 2, 3, 7, 8 consist no column where as row no. 4, 5, 6 consist 2 columns.
- In first row, the name of the company should be written.
- In second row, the subject of the document i.e. Standard Operating Procedure (SOP) should be written.
- In third row, the title of Corresponding SOP is to be mentioned.
- In the first column of fourth row mention SOP No.
- In second column of fourth row write page number: The “page numbering” for the SOP shall be done in the format “Page x of y” at the designated place in the Header. Only the SOP shall be given page numbers in a sequential manner, however, the annexure / format to the SOP shall be page numbered individually .
- In the first and second column of fifth row, mention effective date and review date respectively.
- In the first and second column of sixth row, mention previous and new version.
- In the seventh row, mention originating dept. from which the SOP has been originated / initiated.
- In the last/final row, the distribution list has to be mentioned i.e. the name of the depts. (departments) to which the SOP has to be distributed.
Each page of standard operating procedure consists of footer at the bottom of the page and details as mentioned below:
- All the characters of footer are to be mentioned in Arial 11 font.
- The footer consist a table of three columns and three rows in first page and in remaining pages three columns and two rows.
- First row of each column consist of Prepared By/ Date, Checked By/ Date and Approved By/ Date respectively on each page.
- Person initiating/ preparing, checking/ reviewing and approving the SOP should sign with date in the second row of each page and write full name in third row of first page only in every SOP.
- A person directly supervising the operation shall initiate the creation / revision of an SOP.
- An SOP shall be written after thorough understanding of the operating procedures. The author of the SOP shall have adequate knowledge, training and experience in the related areas of operations.
- An SOP shall be easy to understand / follow and shall depict the sequence of activities logically.
- Wherever necessary, some illustrations, drawings or exhibits may be incorporated in the SOP, to provide better clarity and understanding.
- Wherever abbreviations are used, these shall be elaborated at the first use itself and a summary may be given at the end of the SOP.
Effective / Review date:
- An “Effective Date” in DD-MM-YYYY format (e.g. 01-09-2020 for 1st September 2020) shall be assigned to each SOP, after taking into consideration the necessary training period and creating awareness to all concerned prior to effective date.
- A “Review date” in DD-MM-YYYY format (e.g. 01-09-2022 for 1st September 2022) shall be assigned to each Standard Operating Procedure.
- The review date for an SOP shall be not more than “Two Years”, from the Effective date.
- If there is no change in SOP, during the periodic review, it shall be reprinted incorporating the revised effective date / review date, revision number and the reason for review as ‘Periodic Review’.
- The review shall be completed within 30 days from the “Review Date”.
Body of SOP: Following details shall form the body of SOP.
- The “Objective” shall describe the title & intent of the SOP. An overview of the intent of the SOP shall be briefly mentioned here. Objective of each standard operating procedure is to be started with “To lay down procedure or To establish procedure or To provide a procedure”. Objective of respective standard operating procedure is to be related with the title of the same.
- The “Scope” of SOP shall describe the areas / personnel / equipment / process, to which this SOP is applicable. If there are any specific areas for which the SOP is not applicable, the same may also be mentioned.
- The ‘Responsibility’ shall define the person in-charge for initiating / executing the activity.
- The “Accountability’ indicates the designation of individual accountable for the compliance of the system or procedure defined in the SOP.
- The “Procedure” shall describe the activities to be carried out as a part of SOP.
- A “flow chart”, detailing the steps involved, may be attached in the SOP.
- A suitable “Record format” shall be prepared for recording the control parameters and included as a part of the SOP itself. A unique format number shall be assigned to this format.
- A list of annexure(s), described in the SOP, shall be mentioned (along with annexure number, title, format number and total number of pages of the annexure) in section 6.0.
- References to the current editions of books, operation manual, guidelines, statutory, & regulatory requirements / SOPs may be made (wherever applicable) in the references section 7.0.
- “Reason of Revision” indicates the details of the revision occurred in the same standard operating procedure. If the SOP is not revised/ new, mention not applicable due to first version. Each SOP consists of history chart , in which date of revision and detail of revision or nature of change has to be mentioned.
- List of standard Abbreviation(s) / Acronym(s) used in the SOP may be mentioned, at the end of SOP.
- At the end of the SOP, initiator has to write “END OF SOP” in capital and bold letters.
Annexure Numbering System In Pharma Industry:
- Each Annexure shall be numbered as an alphanumerical number consisting of 11 characters. For example, Annexure for “Quality Assurance ‘general’ SOP” shall be numbered as “QAGN001/A01”.
- In the Annexure number “QAGN001/A01”, the first 7 alphanumerical characters (viz. QAGN001) represent the SOP Number, to which the annexure belongs.
- The 8th character ‘/’ is a forward slash as separator.
- The 9th character ‘A’ denotes ‘Annexure’.
- The last two characters ‘01’ denote the serial number of the annexure, of that particular SOP.
Format Numbering system In Pharma Industry:
- Each ‘record format’ given in an annexure (to be used for data recording), shall have a unique format number for control. Annexure meant for reference purposes only, shall not have format number (for example a flow chart).
- Each “record / documentation format” shall be numbered as an alphanumerical number consisting of 14 characters. For example, first data recording format of SOP QA-GN-001 shall be numbered as QAGN001/F01-00.
- In the format number “QAGN001/F01-00”, the first 7 alphanumerical characters (viz. QAGN001) represent the SOP Number, to which the format belongs.
- The 8th character ‘/’ is a forward slash as separator.
- The 9th character ‘F’ denotes ‘Format’.
- Next two numerical characters ‘01’ denote the serial number of the format, of that particular SOP.
- The 12th character ‘-’ is dash.
- The last two characters denote the ‘revision / version number’ of the format or SOP, starting with ‘00’ and continuing serially in increments of one unit.
Revision of SOP In Pharma Industry:
- An SOP shall be revised, if required by the originating department.
- The person, initiating a revision, may request an uncontrolled copy of the SOP. Handwritten comments may be made & forwarded to department head & for further review.
- Alternatively, a fresh draft of the SOP may be prepared as per the guidelines given in this SOP and forwarded to department head & QA.
- For updating / revising an SOP, the following “SOP change control Procedure” shall be used.
- The initiation of changes in an SOP shall be made as per “SOP change control form”.
- Draft of the revised SOP shall be attached, along with the “SOP change control form” and forwarded to department head / QA for review.
- The department head shall review the changes proposed to ensure compliance and forward it to QA for approval.
- QA shall review the SOP / changes for compliance to cGMP (Current Good manufacturing practices) / regulatory requirements, and approve the same.
- A logbook shall be maintained for recording all the ‘SOP change control form numbers’ assigned and the relevant details).
Initiation of new SOP In Pharma Industry:
- The initiator of SOP shall prepare the SOP draft.
- The SOP initiator shall record the relevant details in “New SOP Initiation Form (SIF)” , attach the SOP draft along with this form and forward it to the concerned department head / QA for review.
- The completeness of draft SOP shall be checked by the concerned departmental head / in-charge, for accuracy of subject matter as well as logical arrangement of data & text.
- After review, the SOP shall be signed (with full signature) & dated, using blue ink ball point pen, in ‘Prepared By’ & ‘Checked By’ columns, along with name written (handwritten) on the first page only. The signed SOP copy shall be forwarded to QA for approval.
- The SOP shall be reviewed by QA for its compliance to cGMP and regulatory requirements.
- Officer QA or above shall assign SIF number as ‘SIF/10/001’ to the “New SOP Initiation Form (SIF)”, where SIF denotes ‘SOP Initiation Form’, ‘10’ represents the year and ‘001’ denotes the sequential serial number of SOP initiation forms.
- Finally, the SOP shall be signed & approved by Head-QA / QA nominee, with the name written (handwritten) on the first page only.
- All the pages of SOP including annexure shall be signed and dated only in blue ink, using ballpoint pen.
- QA shall maintain a logbook for the approved “SOP Initiation Forms”.
Storage In Pharma Industry:
- A hard copy and soft copy (electronic copy) of the approved SOP shall be forwarded to QA department.
- QA shall delete the previous electronic version and store the current version in Computer, for the purpose of viewing only.
- Electronic file shall be named as per the SOP number.
- The “History Sheet” of each SOP shall be updated by respective department and maintained by QA along with the current version of that SOP.
- “History sheet” of an SOP shall be maintained till the SOP is in use. If History sheet is completely filled, a new sheet shall be appended along with filled History sheet.
Training In Pharma Industry:
- For a newly created / revised SOP, training shall be given to the all concerned, if required, depending on nature of changes and SOP parts relevant to their function.
- The training shall be imparted before the effective date and the relevant training records shall be updated in “Training Record” as per SOP on training . Sectional Head / Departmental Head shall ensure that training is imparted to all concerned.
Master List of SOPs:
- QA shall maintain a master list of SOP . It shall contain the list of SOP’s of all the departments along with details of their distribution.
- The list shall be revised quarterly. The list shall be converted into a protected PDF format with print option.
- A hard copy shall be printed and signed by Head-QA / QA nominee and kept in QA records as master copy. To the rest of departments, only controlled copy of master list shall be distributed for use.
- Respective departmental head shall be responsible for maintaining the current version of master list by updating the controlled copy issued.
- If any change takes place in the master list in between a quarterly Updation, manual corrections shall be allowed with the initials of sectional / departmental head and shall be communicated to QA. Such changes shall be incorporated in master list during next quarterly revision by QA.
Master Copy of SOP In Pharma Industry:
- The originally signed copy of an SOP shall be referred to as “Master Copy”. This copy shall be stamped as “Master Copy” in ‘Red ink’, on the front side (at top right corner) and signed & dated.
- The master copies of all SOPs shall be maintained & controlled by QA only.
- Master copies of all SOP shall be filed department-wise, in an orderly manner, along with a proper index.
Distribution / Issuance of Controlled Copies of SOPs In Pharma Industry:
- All the photocopies of the “Master Copy” shall be stamped as “Controlled Copy” and “Copy No.” in Green ink (on bottom of each page) and signed & dated, without obscuring any text.
- Each Controlled copy shall be numbered as per Controlled Copy number for a section / area, which shall be assigned as follows:
|Originating Department||Controlled Copy Reference|
|Production – Oral (Tablets, Capsules & Dry Syrup)||3|
|Personnel & Administration||6|
- If the concerned department is assigned “Controlled Copy No. 4” as distribution copy and requires two copies in the same department, then the controlled copy numbers shall be assigned as ‘4/1’ and ‘4/2’.
- These controlled copies shall be issued by QA, to various departments as per the “distribution list”.
- The “distribution list” shall be developed by QA, in consultation with SOP originating This distribution list may also be reviewed / revised, during the revision of the SOP.
- The department head, for the SOP originating department, shall also communicate the exact number of copies required for his area.
- As per distribution list, QA shall make required number of photocopies from the Master Copy.
- The SOP receiving department may send a request for additional copies to QA, duly approved by department head. This request may be sent through the prescribed SOP requisition form .
- After providing requisite number of copies, QA shall update the distribution record .
- The SOP shall be handed over to the area supervisor and acknowledgement shall be taken on Distribution List Log Book.
- QA shall perform reconciliation of distribution & retrieval of obsolete version of SOPs, for destruction.
- QA shall destroy these retrieved obsolete copies and record in the Distribution List Log Book.
- SOPs received from external location / customer shall be distributed as ‘uncontrolled copy’ only. Concerned department may use these copies as guideline and review the existing SOP for necessary amendments. SOPs of external origin are for reference only.
Deletion of SOP In Pharma Industry:
- In case of discontinuation of an existing operating procedure, the existing SOP may be discontinued / deleted. However, the same SOP number shall not be allotted to any newly created SOP.
- The deletion of SOP shall be initiated by originating department, as per the prescribed.
- Head-QA shall assess the impact, of deletion of that SOP, on the GMP system and accordingly authorize the deletion.
- QA shall record the retrieval / deletion record/ data of SOP as per prescribed format and accordingly master list of SOPs shall be updated.
- Master copy of deleted SOP along with “history sheet” & shall be archived and the electronic copy of SOP shall be deleted from the storage system.
Copies to Regulatory Agencies / Customer copies In Pharma Industry:
- If any Regulatory agency / Customer require a copy of SOP / Document for reference, the copy shall be provided by QA only.
- This copy shall be stamped as “Uncontrolled Copy” in Blue ink and signed & dated on all the pages, before issuance.
Archival of SOP In Pharma Industry:
- After revision of an SOP, all the pages of “previous Master Copy” shall be stamped as “Obsolete Copy” in red ink, on center of each page. These obsolete master copies shall be archived in QA records. Obsolete SOPs shall be deleted from computer system by QA.
- Soft Copy (electronic copy) of current version of SOPs shall be available with QA and backup of electronic copies of SOPs shall be taken on monthly basis in CD/ DVD by QA.
- Obsolete Master copies of SOPs shall be filed separately by QA documentation cell and log shall be maintained
- Such obsolete copies shall be maintained for 10 years (from effective date). After completion of retention period, these shall be destroyed by QA and the record of destruction shall be maintained.
List of Annexures / Formats:
- Not Applicable
References (if any):
- cGMP guidelines.
Reason for Revision:
- New SOP
SOP: Standard operating procedure
QA: Quality Assurance
SCCF: SOP Change Control Form
cGMP: Current Good Manufacturing Practices
cGLP: current Good laboratory Practices
QC: Quality Control
SIF: SOP imitation Form
END OF SOP
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube